Bone health in women with premature menopause
Not Applicable
- Conditions
- Health Condition 1: N912- Amenorrhea, unspecified
- Registration Number
- CTRI/2024/08/072044
- Lead Sponsor
- Research Section Thesis Grant AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects
Women with POI meeting all the following criteria
- Age less than 40 years
- Secondary amenorrhea for at least four months
- Elevated FSH 25.0 IU/L on two occasions at least 4 weeks apart
Controls
- Age and parity matched healthy women with normal menstrual cycles and serum FSH in normal range
Exclusion Criteria
Both subjects and controls
- History of surgery on tubes/ovaries, post radiation, post chemotherapy
- Any systemic illness, History of chronic renal disease
- Hyperthyroidism, hyperparathyroidism
- On corticosteroids and anticonvulsant therapy which are known to affect bone metabolism
- Unwilling to give written informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMD at the spine and hip, TBS, serum levels of Osteopontin, P1NP, Beta Cross LapsTimepoint: At baseline
- Secondary Outcome Measures
Name Time Method - Number of women with POI who have bone density scores less than one standard deviation below the mean of the reference group in spine and/or hip region <br/ ><br>- Correlation of biomarkers levels with BMD & TBS <br/ ><br>- Questionnaire to assess awareness of POI & its impact on bone.Timepoint: At baseline